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Status unknownNCT01776489Updated Dec 11, 2015

Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

An observational study in Food Allergy and Anaphylaxis, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 12 Months to 17 Years. Per ClinicalTrials.gov, last updated 2015-12-11.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
12 Months to 17 Years
Sex
All
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Study summary

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date.

Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).

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Conditions studied

  • Food Allergy
  • Anaphylaxis

Keywords

  • Food allergy
  • Sphingosine-1-phosphate
  • Biomarker
  • Double-blind placebo-controlled food challenge
  • Anaphylaxis
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 70 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children (age 1-17 years) being in medical care at the allergy clinic of the Department of Pediatrics and Adolescent Medicine of the Medical University of Vienna for food related immediate type symptoms (nausea, abdominal pain, vomiting, diarrhea or local symptoms like burning, swelling, itching and erythema) immediately after ingestion of food compounds will be enrolled in this study.

Inclusion criteria

  • Patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to DBPCFC or open provocation
  • Patients who are diagnosed by elevated allergen specific IgE and/or positive skin prick testing
  • Willingness to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate in the study
  • Non-IgE-mediated food allergy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • food allergic

    positive reaction during DBPCFC

  • Non-food allergic

    no reaction during DBPCFC

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What researchers measure

Primary outcomes

  1. S1P in allergic and non-allergic patients before and after challenge

    The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.

    Time frame: up to 3 years

Secondary outcomes

  1. Evaluation of allergic mediators and correlation with S1P levels

    Evaluation of allergic mediators like histamine, human mast cell tryptase and eosinophil cationic protein and correlate these results with the levels of S1P within the group and between allergic and non-allergic patients

    Time frame: up to 3 years

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Study locations

1 of 1 sites recruiting
  • Medical University Vienna, Department of Pediatrics and Adolescent Medicine
    Vienna, 1090, Austria
    • Zsolt Szépfalusi, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • Diesner SC, Olivera A, Dillahunt S, Schultz C, Watzlawek T, Forster-Waldl E, Pollak A, Jensen-Jarolim E, Untersmayr E, Rivera J. Sphingosine-kinase 1 and 2 contribute to oral sensitization and effector phase in a mouse model of food allergy. Immunol Lett. 2012 Jan 30;141(2):210-9. doi: 10.1016/j.imlet.2011.10.006. Epub 2011 Oct 14. Erratum In: Immunol Lett. 2012 Aug 30;146(1-2):79. PubMed 22020265 ↗
  • Olivera A, Eisner C, Kitamura Y, Dillahunt S, Allende L, Tuymetova G, Watford W, Meylan F, Diesner SC, Li L, Schnermann J, Proia RL, Rivera J. Sphingosine kinase 1 and sphingosine-1-phosphate receptor 2 are vital to recovery from anaphylactic shock in mice. J Clin Invest. 2010 May;120(5):1429-40. doi: 10.1172/JCI40659. Epub 2010 Apr 19. PubMed 20407207 ↗
  • Olivera A, Mizugishi K, Tikhonova A, Ciaccia L, Odom S, Proia RL, Rivera J. The sphingosine kinase-sphingosine-1-phosphate axis is a determinant of mast cell function and anaphylaxis. Immunity. 2007 Mar;26(3):287-97. doi: 10.1016/j.immuni.2007.02.008. Epub 2007 Mar 8. PubMed 17346996 ↗
  • Ammit AJ, Hastie AT, Edsall LC, Hoffman RK, Amrani Y, Krymskaya VP, Kane SA, Peters SP, Penn RB, Spiegel S, Panettieri RA Jr. Sphingosine 1-phosphate modulates human airway smooth muscle cell functions that promote inflammation and airway remodeling in asthma. FASEB J. 2001 May;15(7):1212-4. doi: 10.1096/fj.00-0742fje. No abstract available. PubMed 11344091 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01776489
Lead sponsor
Medical University of Vienna
Responsible party
Eva Untersmayr-Elsenhuber (Assoc. Prof., Dr., Medical University of Vienna) — Principal investigator
First posted
Jan 28, 2013
Start date
Dec 2011
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Dec 11, 2015

Study contacts

Zsolt Szépfalusi, MD
Contact
zsolt.szepfalusi@meduniwien.ac.at
+43 1 40400 ext. 3232
Susanne C. Diesner, MD, PhD
Contact
susanne.diesner@meduniwien.ac.at
+43 1 40400
Eva Untersmayr-Elsenhuber, MD, PhD
principal investigator · Medical University Vienna, Department of Pathophysiology and Allergy Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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